Breast CancersNCT00248911
The Effect Of Meditation On Quality Of Life In Women With Breast Cancer And Other Gynecological Cancers
A study testing Mindfulness based meditation program in people with Breast Cancers and Gynecologic Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Women with breast cancer and other gynecologic cancers often suffer significant distress and disability from their disease. A practice of meditation-based stress reduction and cognitive-affective-behavioral learning may help women with these conditions decrease their suffering and improve their quality of life. Read more about this study
- Who is it for?
- Ages 18 to 101 years, women only
- Conditions the study is for
- Breast Cancers, Gynecologic Cancer
- What is being tested?
- Mindfulness based meditation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 101 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All women with stage I-III breast or other gynecologic cancer who have received treatment within the preceding year will be eligible for inclusion in the study.
Who cannot join
- Patients who refuse to participate will be excluded
- Patients with Metastatic cancer are excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College-New York Hospital
New York, New York, 10065
About this study
Official title: The Effect Of Meditation On Quality Of Life In Women With Breast Cancer And Other Gynecological Cancers:Avon Program for Meditation and Healing
Women with breast cancer and other gynecologic cancers often suffer significant distress and disability from their disease. A practice of meditation-based stress reduction and cognitive-affective-behavioral learning may help women with these conditions decrease their suffering and improve their quality of life.
Read the detailed description
The objective of this project in women recently treated for breast or other gynecologic cancer is to determine whether an intervention program consisting of group and individual instruction in a meditation-based practice of stress-reduction and cognitive-affective-behavioral learning has the potential for reducing disabling distress and improving quality of life in a population vulnerable to the progression or recurrence of disease. Quality of life will be assessed at 12 months.
- Conditions
- Breast Cancers, Gynecologic Cancer
- Being tested
- Mindfulness based meditation program
- Keywords
- Breast cancer, Gynecologic cancers, Meditation, Stress-reduction, Cognitive-affective behavioral learning
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness based meditation programBehavioural
Also called Meditation and Breast Cancer
Subjects will participate in an intervention consisting of group and individual instruction in a meditation-based practice of stress-reduction and cognitive-affective-behavioral learning.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness based meditation program | Experimental | Meditation and Breast Cancer: Subjects will participate in an intervention consisting of group and individual instruction in a meditation-based practice of stress-reduction and cognitive-affective-behavioral learning. Receives: Behavioral: Mindfulness based meditation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life will be assessed by within patient differences in the FACT-G (General Functional Assessment of Cancer Treatment Scale), as well as with the disease specific subscales at baseline and at 12 months.
Measured: Subjects will complete questionnaires at baseline and closeout. Patients will participate in the meditation program weekly for 20 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2005 (estimated)
- Study startMay 2003
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancersStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Avon Foundation
- Responsible party
- Principal investigator, Mary E. Charlson, MD, Weill Medical College of Cornell University
- Investigators
- Mary E Charlson, MD, Principal investigator, Weill Medical College of Cornell UniversityJoseph Loizzo, MD,PhD, Principal investigator, Center for Complementary and Intergrative Medicine, New York Presbyterian Hospital-Weill Cornell Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00248911
- Sponsor's protocol ID
- 0209005792
- Status last verified
- Feb 2017
- First submitted
- 3 Nov 2005
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No Plan to Share IPD
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Meditation On Quality Of Life In Women With Breast Cancer And Other Gynecological Cancers:Avon Program for Meditation and Healing
- ClinicalTrials.gov ID
- NCT00248911
- Acronym / sponsor ID
- 0209005792
- Conditions
- Breast Cancers, Gynecologic Cancer
- Keywords
- Breast cancer, Gynecologic cancers, Meditation, Stress-reduction, Cognitive-affective behavioral learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Avon Foundation
- Study start
- May 2003
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 4 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women with breast cancer and other gynecologic cancers often suffer significant distress and disability from their disease. A practice of meditation-based stress reduction and cognitive-affective-behavioral learning may help women with these conditions decrease their suffering and improve their quality of life.
Detailed description
The objective of this project in women recently treated for breast or other gynecologic cancer is to determine whether an intervention program consisting of group and individual instruction in a meditation-based practice of stress-reduction and cognitive-affective-behavioral learning has the potential for reducing disabling distress and improving quality of life in a population vulnerable to the progression or recurrence of disease. Quality of life will be assessed at 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness based meditation program | Experimental | Behavioral: Mindfulness based meditation programMeditation and Breast Cancer: Subjects will participate in an intervention consisting of group and individual instruction in a meditation-based practice of stress-reduction and cognitive-affective-behavioral learning. |
Who may qualify
- Ages
- 18 to 101 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All women with stage I-III breast or other gynecologic cancer who have received treatment within the preceding year will be eligible for inclusion in the study.
Key exclusion criteria (2 listed)
- Patients who refuse to participate will be excluded
- Patients with Metastatic cancer are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness based meditation programAlso: Meditation and Breast CancerSubjects will participate in an intervention consisting of group and individual instruction in a meditation-based practice of stress-reduction and cognitive-affective-behavioral learning. | Behavioural | Mindfulness based meditation program |
Primary outcome
Quality of life will be assessed by within patient differences in the FACT-G (General Functional Assessment of Cancer Treatment Scale), as well as with the disease specific subscales at baseline and at 12 months.
Time frame: Subjects will complete questionnaires at baseline and closeout. Patients will participate in the meditation program weekly for 20 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: No. No Plan to Share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary E Charlson, MD principal investigator
Weill Medical College of Cornell University
Joseph Loizzo, MD,PhD principal investigator
Center for Complementary and Intergrative Medicine, New York Presbyterian Hospital-Weill Cornell Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness based meditation program in people with Breast Cancers and Gynecologic Cancer, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life will be assessed by within patient differences in the FACT-G (General Functional Assessment of Cancer Treatment Scale), as well as with the disease specific subscales at baseline and at 12 months. (time frame: Subjects will complete questionnaires at baseline and closeout. Patients will participate in the meditation program weekly for 20 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.